ASCO 2011 Genitourinary Cancer

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1 ASCO 2011 Genitourinary Cancer Expanding Options for Chronic Diseases? Walter Stadler, MD, FACP University of Chicago Disclosures (All Non-University &/or Financial Dealings with Potential, Real, or Perceived Conflicts of Interest) Consultant: Novartis, Pfizer/Wyeth, Roche/Genentech, Takeda, Caremark/CVS, Aveo, Ligand Pharmaceuticals, NCI/SAIC-Frederick Speakers Bureau: CME providers (sponsorship unknown): Imedex, CME Innovations, Research-to-Practice, Clinical Care Options, Medical Communications Media Pfizer, Bayer Grant/Research Support: Active Biotech, Bayer, Bristol-Myers Myers-Squibb, Boerhinger-Ingelheim, Novartis, Genentech (Roche), Glaxo-Smith-Kline, Medarex, Medivation, Solvay (Abbott), Pfizer, ImClone (Lilly), Amgen, Takeda (Millenium Millenium), NIH, CALGB Stockholder: Abbott (Spouse) Expert Witness None Miscellaneous: Kidney Cancer Assoc, Bladder Cancer Advocacy Network, Up-To To-Date, NexCura 1

2 Renal Cancer: What we Knew Disease natural history is highly variable Prognostic models capture some, but not all of variability VEGF pathway inhibitors slow disease progression Likely improve survival Sequential inhibitors have activity mtor inhibitors have modest anti-tumor tumor activity Survival improved in untreated t poor prognosis patients Progression slowed in post-vegfr TKI setting Combination therapy has increased toxicity Available VEGF Pathway Inhibitors Context of Definitive Trial(s) Agent(s) Comparator No Prior Therapy Prior IL2 or IFNA Prior VEGF Pathway Bevacizumab/IFNA IFNA X Sunitinib IFNA X Sorafenib Placebo X Pazopanib Placebo X X Axitinib Sorafenib X X Tivozanib* Sorafenib X X *Data pending 2

3 Rini, et al: AXIS Trial (abstract 4503) Treatment-refractory metastatic RCC R A N D O M I Z E Axitinib 5 mg BID Sorafenib 400 mg BID 1:1 Randomization stratified by ECOG PS and type of prior treatment Starting dose 5 mg BID with option for dose titration to 10 mg BID Metastatic RCC with clear cell histology Measurable disease per RECIST criteria RECIST-defined progressive disease after one prior sunitinib, bevacizumab + IFN-, temsirolimus, or cytokine-based regimen ECOG Performance Status 0 or 1 5 Survival Progression-Free Subjects at risk, n Axitinib Sorafenib AXIS Results mpfs, mo 95% CI Axitinib Sorafenib P< (log-rank) Stratified HR (95% CI ) Time (months) Quality of life similar in both arms (abstract 4504) Composite time-to-deterioration better with axitinib 6 3

4 PFS by Prior Regimen Prior Treatment Regimen Cytokines (n=251) IRC Investigator Sunitinib (n=389) IRC Investigator Temsirolimus (n=24) IRC Investigator Bevacizumab (n=59) IRC Investigator Axitinib (n=361) Sorafenib (n=362) HR P value* < IRC *One-sided log-rank test stratified by ECOG PS 7 Aitchison, et al: Adjuvant Immunochemotherapy (abstract 4505) High risk localized disease following nephrectomy IL2/IFNA/5FU versus observation 3 year DFS from 50% to 65 % with 90% power and 2-sided alpha = % of pts in experimental arm unable to complete therapy due to toxicity No difference in outcome 4

5 What we learned - RCC Confirmed that sequential VEGFR TKI can have activity it Standard of care for locally advanced renal cancer following resection is observation What Do We Need to Know? What are the predictors of benefit from IL2 based, VEGF, or mtor pathway directed therapy? Tumor characteristics Stroma characteristics Host characteristics Is continued/life-long long VEGF pathway inhibition important? What are the mechanisms of resistance to VEGF pathway inhibition 5

6 What Do We Need to Know? Are there other/better therapeutic targets than the mtor and VEGF pathways? Are there better ways to therapeutically target VHL pathway inactivation in ccrcc? What are the most appropriate therapeutic targets in papillary or chromophobe RCC? Can we afford personalized long-term therapy? $ Toxicity Prostate Cancer: Androgen Ablation 6

7 Androgen Ablation & Prostate Ca The androgen receptor is the most important therapeutic target in PCa Targeting AR is effective in >90% The AR is critical even in the castrate resistant state Targeting AR is not curative Androgen ablation has toxicity Bone, muscle, sex Toxicity minimal in comparison to other cancer therapies Intermittent vs. Continuous Intermittent therapy not associated with worse outcome Intermittent LHRH agonist is not intermittent ADT Suggestion of improved sexual function and QOL Similar observations in post-rt population (Crook, et al, abstract 4514) How early should ADT start? 7

8 Abiraterone/TAK-700 COU-AA-301 Study Design Patients 1195 patients with progressive mcrpc Failed 1 or 2 chemotherapy regimens, one of which contained docetaxel R A N D O M I Z E D 2:1 Abiraterone 1000 mg daily Prednisone 5 mg BID n=797 Placebo daily Prednisone 5 mg BID n=398 Efficacy endpoints (ITT) Primary end point OS (25% improvement; HR 0.8) Secondary endpoints (ITT) TTPP PFS PSA response Phase III, multinational, multicenter, randomized, double-blind, blind, placebo-controlled controlled study (147 sites in 13 countries; USA, Europe, Australia, Canada) Stratification according to ECOG performance status (0-1 vs 2) Worst pain over previous 24 hours (BPI short form; 0-3 [absent] vs 4-10 [present]) Prior chemotherapy (1 vs 2) Type of progression (PSA only vs radiographic progression with or without PSA progression) Abbreviations: BPI=Brief Pain Inventory; TTPP=time to PSA progression; ITT=intent to treat; mcrpc=metastatic castrate-resistant prostate cancer. Source: Clinicaltrials.gov identifier: NCT

9 100 COU-AA-301: Abiraterone Acetate Improves OS in mcrpc 80 HR=0.646 ( ) P < Abiraterone: 14.8 months (95% CI: 14.1, 15.4) Overall Survival, % Placebo: 10.9 months (95% CI: 10.2, 12.0) 1 Prior Chemo OS: 15.4 months abiraterone vs 11.5 months placebo Days from Randomization Abiraterone Placebo Logothetis, et al: Symptomatic Improvement Pain Intensity Palliation (abstract 4520) Patients experiencing palliatio on 70% 60% 50% 40% 30% 20% 10% 0% P = /349 (44.4%) 44/163 (27.0%) AA (n = 797) Placebo (n = 398) 9

10 Scher, et al: CTC as Surrogate Endpoint (LBA 4517) In the context of the Abiraterone phase 3 trial: CTC prognostic CTC decline predictive of trial survival outcome Applicable to other trials? Applicable to individual patients? Hussain, et al: Cabozantinib (abstract 4516) PR or CR Open-Label Extension Cabozantinib Discontinue Cabozantinib 12-Week Lead-In Stage: Open-Label Cabozantinib 100 mg PO, QD Week 12 SD Tumor Staging PD Blinded Randomized Stage Cabozantinib vs. Placebo (1:1) Discontinue Cabozantinib Unblind at Progression Placebo Cross-Over to Cabozantinib CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease (per mrecist 1.0) 10

11 mcrpc Patient Disposition Enrolled: N = 171 Randomization was suspended after 122 patients because of early clinical benefit Open-Label Extension Week 12 a n = 79 (46%) Active 52 Discontinued 27 Randomized at Week 12 n = 31 (18%) Cross-over to Cabozantinib 14 Active 4 Discontinued 13 Off Study Treatment Week 12 n = 61 (36%) Disease Progression 28 (16%) Adverse Event 25 (15%) Death 1 (1%) Other b 7 (4%) a Includes patients with SD at Week 12 following suspension of randomization b Includes withdrawal (n = 2), not compliant (n = 1), request (n = 3), lost to follow up (n = 1) Progression-Free Survival for Patients Randomized to Placebo or Cabozantinib (N = 31) Proportion Progression-Free Median PFS Cabozantinib (n = 14) 21 weeks Placebo (n = 17) 6 weeks (HR 0.13; log-rank p-value ) Week Lead-in Stage PFS per mrecist, Post Randomization (Weeks) PFS (95% CI) # Events Cabozantinib (11, NE) 6 Placebo (5, 12) 11 11

12 Bone Scan Effects: Representative Images Baseline Week 12 Baseline Week 12 Baseline Week 12 Baseline Week 12 Docetaxel-pretreated Docetaxel-pretreated Docetaxel-pretreated Docetaxel-naïve Each Patient had PR + Pain Improvement Best Overall Effect on Bone Scan Bone scan evaluable (N = 108) a n (%) Complete resolution 21 (19) Partial resolution 61 (56) Stable 23 (21) Progressive disease 3 (3) a Bone metastases at baseline and 1 post-baseline bone scan available 12

13 A Met/VEGFR inhibitor? VEGF pathway inhibition not effective CALGB docetaxel ± bevacizumab Prednisone/Sunitinib vs. Prednisone (abstract 4515) No similar dramatic reports in early phase studies of reported Met or HGF inhibitors Others being tested Ongoing cabozantinib trials Phase 3 efficacy with pain endpoints Imaging & biopsy trials to understand stromal vs. tumor specific effects Prostate Cancer 2011 Advanced prostate cancer pts can have a long history Opportunity for multiple therapies Toxicities and quality of life important Issues of co-morbid disease and aging Philosophy of chronic d. management Androgen receptor pathway targeting is key DNA targeted chemotherapy plays a role Immunotherapy may play a role Bone stromal targeting plays a role Bisphosphonates/denosumab for bony morbidity Radioactive bone targeting nuclides Met inhibitors? 13

14 What do we need to know? When do we start ADT? How early do we start more potent AR targeting agents? When do we introduce non-ar targeting therapy? Can we afford personalized long-term therapy? $ Toxicity Bladder Cancer 2012??? 14

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